Salivary Gland Transplantation in the Treatment of Dry Eye in Patients With Stevens-Johnson Syndrome.

Not Applicable

Completed

• Conditions: Transplantation; Symblepharon; Dry Eye; Ocular Surface Disease
• Interventions: Procedure: Salivary Gland and Labial Mucous Membrane Transplantation

• Registration Number: NCT01178242
• Lead Sponsor: Federal University of São Paulo

Brief Summary

The purpose of this study is to evaluate salivary gland and labial mucous membrane transplantation in patients with severe symblepharon and dry eye secondary to Stevens-Johnson Syndrome (SJS).

Detailed Description

This study was performed to evaluate the use of salivary gland and labial mucous membrane transplantation in patients with severe symblepharon and dry eye secondary to SJS. Labial mucous membrane and salivary gland transplantation showed to be a good option in the treatment of severe symblepharon and dry eye secondary to SJS. labial mucous membrane, salivary glands, symblepharon, entropion, transplantation, graft.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2010-01-19
• Primary Completion: 2010-04
• Study First Submitted QC: 2010-08-09
• Study First Posted: 2010-08-10
• Study Completion: 2010-12
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-09
• Last Update Posted: 2016-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Only patients with poor visual acuity, less or equal to 20/200, and Schirmer I test equal to zero.
• Eyes with symblepharon or ankyloblepharon that did not allow the placement of a Schirmer test strip will be consider not measurable.

Exclusion Criteria

• Active infection and corneal melting or perforation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Salivary Gland and Labial Mucous Membrane Transplantation	Salivary Gland and Labial Mucous Membrane Transplantation	-

Primary Outcome Measures

Name	Time	Method
A Complete ophthalmic exam including Schirmer I test , slit lamp exam, fundoscopy will be perform before and six months after surgery. Symptons improvement considered positive if patients will refer improvement of eye moisturasing and motility.	6 months

Trial Locations

Locations (1)

UNIFESP; 🇧🇷 Sao Paulo, SP, Brazil